Regulatory Affairs

Our team specializes in offering the following services

• Product classification

  As part of our process, we evaluate products to determine their category or group based on the regulations of the health authority responsible for registration. This ensures products are appropriately positioned within the relevant regulatory framework, providing clients with the most efficient alternatives in terms of procedures and costs.

• Registrations, renewals, and notifications

  Our team assists clients in obtaining the permits, registrations, and authorizations needed for their products' commercialization. We also notify clients of renewal deadlines and provide support throughout the renewal process.

• Registration modifications

  Any changes to a product or its manufacturing process must be reported to the Health Authority. We actively support clients in this process, ensuring compliance, regulatory efficiency, and the proper steps for product commercialization.

• NOC (non-obligatory certification)

  For products not requiring health registration, we offer evaluations to determine their eligibility and guide clients through the certification process.

• Certificate for export

  Our team is highly qualified in assisting local manufacturers in securing permits for exporting their products.

• Free sale certificate

  Supporting the process of obtaining certificates for domestically produced goods intended for export.

• Controlled substance certificates

  We assist clients whose products contain controlled substances requiring a specific certificate for commercialization.

• Health authority authorizations

  We advise clients on obtaining health authority documents for specific procedures, including:

  • Advertising
  • Product and label exhaustion
  • Food additives
  • Promotional incentives
  • Non-available vital products

• Device and reagent coding (UDI-DI)

  We help medical device and IVDR manufacturers to prepare and submit necessary data for compliance with UDI-DI standards.

• Certification support

  We provide comprehensive support in obtaining product-specific certifications that ensure their commercial viability. We participate in every stage of the process, increasing the likelihood of success. Certifications include:

  • Sanitary conditions
  • Sanitary and technical decision
  • Production capacity
  • Certificate for capacity of storage and conditioning
  • GMP (Good Manufacturing Practices)
  • HACCP (Hazard Analysis and Critical Control Points)

• Specialized advisory

  For products with ingredients, claims, or uses requiring specialized review, we offer consulting services to prepare applications for consideration by regulatory authorities.

• Post-market surveillance

  Assistance in creating and managing post-commercialization surveillance reports for medical devices.

• Pharmacovigilance

  Support for pharmaceutical product surveillance, generating required reports for health authorities.

• Regulatory assistance at ports of entry

  We handle regulatory matters during product importation, ensuring compliance for market entry.

• Sanction proceedings

  We advise clients under regulatory sanctions, designing strategies to ensure due process and favorable outcomes.

• Facility registration

  For food products, we assist in registering manufacturing facilities as required by regulatory entities.

• Label compliance

  We review labels for regulatory compliance and create models for nutritional labeling, including nutritional tables, warning seals, and applicable claims.

• Compliance certificates

  We support obtaining certificates that confirm compliance, such as sodium content certification for food products.

• Technical-legal opinions

  We provide tailored technical and legal opinions based on applicable regulations and our extensive experience.

• Regulatory due diligence

  We assess the regulatory status of a client's product portfolio and develop strategies for commercial viability.

• Toxicology reports

  We assist in obtaining toxicity reports and classifications for pesticide products.

• Regulatory hosting services

  For foreign companies unable to hold registrations, we offer hosting services, acting as their representative for regulatory purposes in the required countries.

• Translations and legalizations

  We translate technical and legal documents for regulatory processes, offering both simple and official translations as needed.

• Specialized consulting

  We tailor regulatory strategies and provide specific solutions to meet our clients' needs.